- Regulatory/Clinical Writer creates documents intended to support Health Authority interactions and filings, such as briefing documents, INDs/ CTAs, and marketing applications. Included in the scope are medical writing activities as well as some CMC technical writing, as necessary.
- Proficient in the principles of scientific writing, conveys messages in a clear and concise manner, while maintaining compliance with global (FDA, EMA, ICH) regulatory expectations for document content.
- Analyzes, interprets, and distills data and other information to author documents.
- Demonstrates subject matter expertise of relevant regulatory requirements and corporate policies to assess document content expectations and identify information gaps or other potential issues. Takes appropriate steps to resolve any identified issues.
- Collaborates with cross-functional colleagues on content authoring, advising the team on regulatory expectations for document content, and leading through comment resolution.
- Independently authors complex documents compliant with relevant internal processes and standards as well as external regulatory guidance. Demonstrates subject matter expertise.
- Provides strategic and operational leadership to direct preparation and completion of documents. Collaborates cross-functionally with subject matter experts to ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
- Drives decision making about data presentation strategies to support advance planning of documents. Engages early with project teams and subject matter experts to plan and review tables, listings, and figures for assigned documents.
- Collaborates with Medical functions on authoring of documents intended to support clinical trials including (but not limited to) protocols, IBs, clinical study reports, clinical summaries for marketing applications, and responses to queries from regulatory authorities.
- Collaborates with the CMC SMEs on generation of CMC-focused sections of briefing documents, DMFs, INDs/CTAs, and technical reports, as necessary.
- Works with Project Management and Regulatory Affairs functions to establish appropriate timelines and identify contingencies for delivery of assigned documents in a timely manner.
- Master's Degree or PhD, preferably in a life science discipline. Experience in regulatory/clinical writing - BS/BA, MS/MA or PhD minimum 5 years of experience. Ability to collaborate successfully with all levels and roles in cross-functional, global teams.
- Ability to manage documents of greater complexity and/or variety.
- Ability to multi-task and work effectively under pressure, with strong organizational and project management skills.
- Develops options or possible solutions to resolve complex problems that impact project completion and/or document content strategy. Demonstrates critical and rapid decision-making.
- Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.
- Analytic skills. Ability to examine data and formulate reasonable hypotheses.
- Knowledge of how to use publicly available databases (eg, PubMed, DailyMed, FDA, and EMA sources and guidelines) for literature and information mining to support document content and how to cite such information appropriately.
- Able to consolidate, analyze, interpret, and summarize data from multiple data sources
- Capable of leading discussions of benefit/risk assessment and regulatory impact of documents and analyses, without guidance.
- Track record of communicating complex information and analyses effectively in writing to a variety of scientific and nonscientific audiences.
- Demonstrated proficiency with Microsoft Word (above average knowledge) and other relevant software (eg, PowerPoint, Excel).